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Diss Factsheets
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EC number: 200-681-6 | CAS number: 68-22-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 02/1970 - 07/1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- After appropriate acclimation period female rabbits were mated with male animals. 20 Pregnant mice per dose group were orally administered norethisterone acetate at doses of 12 and 48 mg/kg bw/day during GD 7-13, in each group 5/20 dams were allowed to deliver spontaneously. The other dams were sacrificed on day 18 of gestation, fetuses were removed from dams via section. All animals were examined macroscopically.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Norethisterone acetate
- EC Number:
- 200-132-0
- EC Name:
- Norethisterone acetate
- Cas Number:
- 51-98-9
- Molecular formula:
- C22H28O3
- IUPAC Name:
- 17-ethynyl-3-oxoestr-4-en-17-yl acetate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: tragacant 1%
- Duration of treatment / exposure:
- day 7- 13 of gestation
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 12 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 48 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 (15 caesarean section, 5 spontaneous delivery)
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 48 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no effects observed
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 12 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in postnatal survival
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
No prenatal developmental toxicity studies were conducted with ZK 5378 (norethisterone). Results of studies conducted with an ester of norethisterone (norethisterone acetate, ZK 5422) are regarded as representative as most likely ester cleavage occurs in vivo after administration.
In a test where pregnant mice of Day 7-13 received doses of 48 and 12 mg/kg p.o., the number of perinatal death increased at a dose of 48 mg/kg. No teratogenic effects were observed at both doses.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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